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CompletedNCT05276739LipidPRCUpdated Aug 6, 2026

Role of Photic and Non-photic Time Cues in Resetting Circadian Rhythms

An interventional study of Bright Light and Time-restricted eating in Light Exposure and Meal Timing, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
All
01

Study summary

The aim of this study is to determine the principal time cue (light or meals) for resetting circadian rhythms in melatonin and metabolic outcomes.

Read the detailed description

The objective of this proposal is to construct and compare PRCs describing the relationship between the timing of light exposure and meals across the 24-hour day and the size and direction of shift in circadian rhythms of circulating lipids and melatonin in humans. Completion of the work will provide mechanistic insight on the role of photic and non-photic cues mediating entrainment of circadian rhythms in humans besides that of melatonin. In this proposal, we will use the same experimental paradigm that we have successfully used previously to characterize and compare PRCs for shifts in melatonin in response to light exposure of different durations and spectra, and as used in our pilot trials demonstrating a robust PRC of lipid circadian rhythms in response to combined photic and non-photic stimuli across the day. We will achieve our objective using a randomized controlled trial in young healthy adults (n=48, 18-30 years) that systematically manipulates the timing of 6.5-hour bright light exposure and 6.5-hour time restricted eating across the 24-hour circadian cycle to specifically:

Aim 1: Determine if light is the primary time cue for resetting melatonin but not lipid circadian rhythms. Hypothesis: The resetting response of circadian rhythms in melatonin but not cholesterol and triglycerides is dependent upon the circadian phase at which a 6.5-hour bright light exposure occurs.

Aim 2: Determine if meal timing is the primary time cue for resetting lipid but not melatonin circadian rhythms. Hypothesis: The resetting response of circadian rhythms in cholesterol and triglycerides but not melatonin is dependent upon the circadian phase at which a 6.5-hour time restricted eating occurs.

Aim 3 (Exploratory): Evaluate the acute effects of eating across the 24-hour day on circulating lipid levels. Hypothesis: The acute effects of 6.5-hour time restricted eating on circulating cholesterol and triglycerides levels are dependent on the circadian phase at which meals are eaten.

02

Conditions studied

  • Light Exposure
  • Meal Timing
03

In context

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Aged between 18-30 years
  • Healthy (no medical, psychiatric or sleep disorders;
  • Non-smoking for at least 6 months;
  • Body Mass Index of >18 or \<30 kg/m2;
  • Able to maintain 8-hour consistent sleep schedule during the study
  • Able to refrain from caffeine, alcohol, medication and supplements during the study

Exclusion criteria

Exclusion Criteria:

  • History of alcohol or substance abuse;
  • Positive result on drugs of abuse urine toxicology;
  • Current or past history of sleep disorders, including but not limited to obstructive sleep apnea, narcolepsy, insomnia, or any significant sleep complaint
  • Psychiatric disorder, or first degree relative with a psychiatric disorder
  • Recent acute or chronic medical disorder
  • Use of drugs or medication (birth control OK) likely to affect sleep, alertness or light sensitivity, as determined by the investigators
  • Visual disorder, including but not limited to color blindness, or family history of glaucoma
  • Pregnancy or lactation
  • Shift work (past 3 years)
  • Transmeridian travel (2 or more time zones) in the past 3 months
  • Any other reason as determine by the Principal Investigator
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Bright light

    Participants will receive a 6.5-hour 10,000 lux light pulse (4100K fluorescent light) centered within the 16-hour wake episode (start 4.75 hour after wake and end 11.25 hour after wake). Participants will receive 4 identical meals (equal calories and macronutrient content), over a 12-hour interval (meals at 2, 6, 10, and 14 hours after waking) centered within the 16-hour wake episode.

    Behavioral: Bright Light · Behavioral: 12-h meal window

  • Experimental
    Time-restricted eating

    Participants will consume 4 identical meals, as in the other groups, except that the meal window will be restricted to 6.5 hours instead of 12 hours (meals at 4.75, 6.9, 9.1, 11.25 hours after waking) centered within the 16-hour wake episode. Participants will remain in dim light (\<3 lux) throughout the 16-hour wake episode.

    Behavioral: Time-restricted eating · Behavioral: Dim light

  • Sham comparator
    Control

    Participants will receive 4 identical meals (equal calories and macronutrient content), over a 12-hour interval (meals at 2, 6, 10, and 14 hours after waking) centered within the 16-hour wake episode. Participants will remain in dim light (\<3 lux) throughout the 16-hour wake episode.

    Behavioral: Dim light · Behavioral: 12-h meal window

Interventions

  • BehavioralBright Light

    6.5-hour 10,000 lux light pulse (4100K fluorescent light) centered within the 16-hour wake episode (start 4.75 hour after wake and end 11.25 hour after wake).

  • BehavioralTime-restricted eating

    6.5-hour restricted meal window (4 meals at 4.75, 6.9, 9.1, 11.25 hours after waking) centered within the 16-hour wake episode.

  • BehavioralDim light

    dim light (\<3 lux) throughout the 16-hour wake episode

  • Behavioral12-h meal window

    12-hour restricted meal window (4 meals at 2, 6, 10, and 14 hours after waking) centered within the 16-hour wake episode.

06

What researchers measure

Primary outcomes

  1. Amplitude of Phase Response Curve of melatonin

    Amplitude of phase response curve of melatonin derived by fitting a sinusoidal regression to the individual phase shift data across \~24 hours

    Time frame: 24 hours

  2. Amplitude of Phase Response Curve of triglyceride

    Amplitude of phase response curve of triglyceride derived by fitting a sinusoidal regression to the individual phase shift data across \~24 hours

    Time frame: 24 hours

  3. Amplitude of Phase Response Curve of cholesterol

    Amplitude of phase response curve of cholesterol derived by fitting a sinusoidal regression to the individual phase shift data across \~24 hours

    Time frame: 24 hours

Secondary outcomes

  1. Area under the curve (AUC) of melatonin

    AUC of melatonin

    Time frame: 6.5 hours during intervention

  2. Area under the curve (AUC) of triglyceride

    AUC of triglyceride

    Time frame: 6.5 hours during intervention

  3. Area under the curve (AUC) of cholesterol

    AUC of cholesterol

    Time frame: 6.5 hours during intervention

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05276739
Lead sponsor
Brigham and Women's Hospital
Responsible party
Shadab A Rahman (Assistant Professor, Brigham and Women's Hospital) — Principal investigator
First posted
Mar 11, 2022
Start date
Jul 29, 2022
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026
Last update
Aug 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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